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PACCT-1 TAILORx Follow-up Form NCT00310180 Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial) Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=05DF4324-6BB2-192D-E044-0003BA3F9857

Link:

https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=05DF4324-6BB2-192D-E044-0003BA3F9857

Keywords:

Clinical Trial

Breast Neoplasms

Follow-Up Studies

Versions (5)

8/26/12 8/26/12 -
1/8/15 1/8/15 - Martin Dugas
6/8/15 6/8/15 -
6/8/15 6/8/15 -
9/20/21 9/20/21 -

Uploaded on:

September 20, 2021

DOI:

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Creative Commons BY-NC 3.0 Legacy

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PACCT-1 TAILORx Follow-up Form NCT00310180

English 1

English

Details

No Instruction available.

1 forms

StudyEvent: PACCT-1 TAILORx Follow-up Form
1. No Instruction available.

Header

ECOG Protocol Number

ECOG Patient ID

DCI Name

Registration Step

Follow-up Report Period

Follow-up Report Period (since registration - Choose one x)

6 Months (6 months post registration)

12 Months (12 months post registration)

18 Months (18 months post registration)

2 Years (24 Months post registration)

21 more items in the detailed view.

Reporting period

Reporting Period Start Date (mm/dd/yyy)

Reporting Period End Date (mm/dd/yyy)

Breast: Vital Status

Patient Vital Status

Alive (Alive)

Dead (Dead)

Date of Last Contact or Death (mm/dd/yyy)

Primary Cause of Death (if applicable)

Due To Protocol Treatment (Due to protocol treatment)

Due To This Disease (Due to this disease)

Due To Cardiovascular Disease (Due to cardiovascular disease)

Due To Other Chronic Disease (Due to other chronic disease)

3 more items in the detailed view.

Describe cause of death

Breast: Disease Follow-up Status

Date of Last Clinical Assessment (only provide date if assessment since submission of previous follow-up form)

Not done (Check here and skip the rest of Section II if a more recent clinical assessment was not done.)

Breast: Notice Of Progression - Advanced Disease

Has the patient been diagnosed with first ipsilateral breast tumor recurrence (since submission of the last follow-up form)

Yes

Date of first ipsilateral breast tumor recurrence (If yes:)

Method of Diagnosis (For contralateral breast primaries:)

Radiologic (Radiologic)

Histology (Histologic)

Radiologic And Histologic (Radiologic and Histologic)

Other (Other)

Specify

IBTR histology (NOTE: See TAILORx Forms Completion Guidelines for IBTR definitions)

Invasive Carcinoma (Invasive Carcinoma)

Ductal Carcinoma In Situ (Ductal carcinoma in situ)

Both Invasive Carcinoma And Ductal Carcinoma In Situ (Both invasive carcinoma and DCIS)

Iib - Local-regional Recurrence

Has the patient been diagnosed with first local-regional recurrence or progression (since submission of the last follow-up form)

Yes

Date of First Local-Regional Recurrence (If yes: - mm/dd/yyyy)

Site of first local-regional recurrence (s check all that apply; all sites refer to the same side as the original primary)

Ipsilateral Axillary Lymph Nodes And/or Soft Tissue (Ipsilateral axillary lymph nodes and/or soft tissue)

Ipsilateral Internal Mammary Nodes (Ipsilateral internal mammary nodes)

Ipsilateral Infraclavicular Nodes (Ipsilateral infraclavicular nodes)

Ipsilateral Supraclavicular Nodes (Ipsilateral supraclavicular nodes)

Ipsilateral Chest Wall (Ipsilateral chest wall)

Method of Diagnosis (For contralateral breast primaries:)

Radiologic (Radiologic)

Histology (Histologic)

Radiologic And Histologic (Radiologic and Histologic)

Other (Other)

Specify

Iic - Distance Recurrence

Has the patient been diagnosed with first distant recurrence/progression? (since submission of the last follow-up form)

Yes

Date of First Distant Recurrence (mm/dd/yyyy)

Site(s) of First Distant Recurrence (Indicate - check all that apply at the completion of the metastatic workup)

Bone (Bone(s))

Central Nervous System (Central Nervous System (e.g., brain, meninges))

Liver (Liver)

Lung (Lung(s))

4 more items in the detailed view.

Other specify

Method of Diagnosis (For contralateral breast primaries:)

Radiologic (Radiologic)

Histology (Histologic)

Radiologic And Histologic (Radiologic and Histologic)

Other (Other)

Specify

Section Iii - New Primary Cancers

Has a new primary cancer or MDS been diagnosed that has not been previously reported?

No (No)

Yes, Ductal Carcinoma In Situ Of Contralateral Breast (Yes, ductal carcinoma in situ of contralateral breast)

Yes, Invasive Disease In Contralateral Breast (Yes, invasive disease in contralateral breast)

Yes, Ductal Carcinoma In Situ Of Ipsilateral Breast (Yes, DCIS of ipsilateral breast)

Yes, All Other Sites (Yes, all other sites)

Site of New Primary (Recommended term - CRF shows "specify sites")

Date of diagnosis (If yes: - )

Method of Diagnosis (For contralateral breast primaries:)

Radiologic (Radiologic)

Histology (Histologic)

Radiologic And Histologic (Radiologic and Histologic)

Other (Other)

Specify

Section Iv - Treatment

Has the patient received any chemotherapy during this reporting period?

No (No)

Yes, Chemotherapy Continuing (Yes, chemotherapy continuing)

Yes, Chemotherapy Completed (Yes, chemotherapy completed)

Not Applicable (Not Applicable)

Has the patient received any hormone therapy during this reporting period?

Yes

Did patient switch type of hormonal therapy during this report period

Yes

Specify reason for switch in endocrine therapy (If yes,)

Planned Switch For Therapeutic Reason (Planned switch for therapeutic reason)

Adverse Events From Prior Hormonal Therapy (Adverse events from prior hormonal therapy)

Both Planned Switch For Therapeutic Reason And For Adverse Events From Prior Hormonal Therapy (Both)

Other (Other)

Other, specify

Start date of new hormonal therapy

Specify new type of hormonal therapy given

Aromatase Inhibitor (Aromatase Inhibitor)

Other (Other)

Tamoxifen (Tamoxifen)

Other, specify

Specify which Aromatase Inhibitor was given (If aromatase inhibitor:)

Anastrozole (ANASTROZOLE)

Exemestane (EXEMESTANE)

Letrozole (LETROZOLE)

Other (Other)

Other, specify

Tamoxifen (Answer Yes or No for each of the following therapies the patient consistently took during this reporting period:)

Yes

Aromatase Inhibitor

Yes

Specify which Aromatase Inhibitor was given

Anastrozole (ANASTROZOLE)

Letrozole (LETROZOLE)

Exemestane (EXEMESTANE)

Other (Other)

Specify

Other

Yes

Specify (If yes, specify)

Did patient receive Ovarian Function Suppression (OFS) during this follow-up period?

No (No)

Yes (Yes)

Unknown (Unknown)

Ovarian Function Suppression Type

Medical Suppression Of Ovarian Function (Medical suppression)

Bilateral Surgical Oophorectomy (Oophorectomy)

Other (Other)

Radiation Therapy (Ovarian radiation)

Other, specify

Was all hormonal therapy discontinued this report period

Yes

Date any hormonal therapy last given (If yes, - mm/dd/yyyy)

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Investigator Signature

Investigator Signature Date

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